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临床试验/NCT04320875
NCT04320875Unknown不适用

Stimulate Brain to Reduce Pain Among Patients With Knee Osteoarthritis

Maharishi Markendeswar University (Deemed to be University)0 个研究点目标入组 80 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
Digitalized pain pressure algometer (ALGO-DS-01)

研究概览

简要总结

Osteoarthritis (OA) knee is chronic, slowly progressive, degenerative disease of joint which affects articular cartilage and accompanied by pain, swelling and loss of function . OA is often considered as the serious joint disease as it has negative impact on quality of life among elderly population, it is the major cause for the reduced mobility. At cental level, due to imbalance in endogenous pain modulation there is reduce capacity of brain to inhibit the pain. Therefore, dysregulation in the central modulation of pain further leads to maladaptive changes in the brain structure. Transcranial direct current stimulation is a non-invasive method to modulate the brain structure by using a week direct current applied through the scalp in painless way. Multi-session for prolonged time can induce neuroplastic changes in the brain.

The aim of the study is to demonstrate the effectiveness of tDCS in reducing the pain among patients with chronic knee OA and to modulate the plastic changes in brain structure.

A total of 80 patients with KOA will be recruited by the convenience sampling to participate in this two group pretest-posttest, double blinded randomized clinical study. After the demographics, recruited 80 patients with KOA will be randomly divided into two groups, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group with by block randomization. Patients with KOA in tDCS group will be provided with Active tDCS and conventional physiotherapy and CPT group will receive structured exercises protocol. Pre-post changes in the outcome measures will be documented at baseline and end of 8-week post intervention. Each session will last for approximately 30 minutes duration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study

排除标准

  • Unwillingness to participate in the study
  • Recent history (within the last 3 months) of physical therapy to the same joint
  • Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee
  • History of knee surgery/fracture
  • Acute synovitis/arthritis including the infectious conditions
  • Taking pain relief medications
  • Any metal implantation near site of stimulation

结局指标

主要结局

Digitalized pain pressure algometer (ALGO-DS-01)

时间窗: Changes will be measured at baseline and end of 8 week intervention

Pain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA.

次要结局

  • Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)(Changes will be measured at baseline and end of 8 week intervention)

研究者

发起方
Maharishi Markendeswar University (Deemed to be University)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asir John Samuel

Associate Professor

Maharishi Markendeswar University (Deemed to be University)

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